EUDAMED 2026: Compliance becomes mandatory – Take action now!

The Official Journal of the EU (OJEU) publication of November 27, 2025 marks a turning point: the first 4 EUDAMED modules will be mandatory from May 28, 2026

On November 27, 2025, the European Commission officially published in the Official Journal of the European Union (OJEU) a decision confirming the functionality of the first four EUDAMED modules: Actors, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance.

From May 28, 2026, their use will be mandatory for all manufacturers, authorized representatives, importers, and other stakeholders in the medical device sector.

This date is a point of no return: after this deadline, any non-compliant company faces major risks:

• Ban on marketing your medical devices in the EU.

• Administrative and financial penalties for non-compliance with MDR (EU 2017/745) and IVDR (EU 2017/746) regulations.

• Disruption of the supply chain, affecting your business partnerships and reputation.

• Potential shortages for patients and healthcare professionals, in case of forced product withdrawal.

Why is this deadline crucial?

EUDAMED is the EU’s central database for the traceability and transparency of medical devices. Its phased deployment aims to enhance patient safety and regulatory compliance. From now on, ignorance is no longer an excuse: the OJEU publication officially establishes the obligation to register and declare.

How to prepare effectively?

Achieving compliance requires a structured approach and appropriate tools. Here are the solutions available to support you:

1. Training and Awareness

• Online training on MDR/IVDR requirements and EUDAMED procedures.

• Webinars and workshops led by regulatory affairs experts.

2. Software Tools to Simplify Compliance

• UDI generation and management: automated solutions to create, validate, and manage your Unique Device Identifiers (UDIs).

• Centralization and traceability of UDI data: dedicated platforms to organize and track your data in real time.

• Automation of EUDAMED registrations: software to submit your data accurately and on time.

• UDI label creation tools: solutions to generate compliant labels and barcodes.

3. Document Analysis and Data Preparation

• Data audit and validation before submission, to avoid rejections or delays.

• Document analysis tools to ensure your technical files and declarations are complete and compliant.

4. Human Support from Experts

• QARA (Quality & Regulatory Affairs) consultants: tailored support to assess your needs, correct gaps, and optimize your processes.

• Regulatory affairs assistance: valuable help to navigate the complexities of MDR/IVDR regulations.

5. SaaS Solutions and Integrations

• SaaS software for centralized management of your regulatory data, with automatic updates based on EUDAMED developments.

• Interfaces with your existing systems (ERP, PLM) for seamless synchronization.

Don’t let time catch you off guard

EUDAMED compliance is not an option, but a legal requirement. Companies that anticipate and equip themselves with the right tools minimize risks and gain efficiency.

Our advice: Start now with an audit of your current situation, identify gaps, and implement an action plan with expert help if needed.